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https://www.readbyqxmd.com/read/29310685/what-are-the-main-inefficiencies-in-trial-conduct-a-survey-of-ukcrc-registered-clinical-trials-units-in-the-uk
#1
Lelia Duley, Alexa Gillman, Marian Duggan, Stephanie Belson, Jill Knox, Alison McDonald, Charlotte Rawcliffe, Joanne Simon, Tim Sprosen, Jude Watson, Wendy Wood
BACKGROUND: The UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Units (CTUs) Network aims to support high-quality, efficient and sustainable clinical trials research in the UK. To better understand the challenges in efficient trial conduct, and to help prioritise tackling these challenges, we surveyed CTU staff. The aim was to identify important inefficiencies during two key stages of the trial conduct life cycle: (i) from grant award to first participant, (ii) from first participant to reporting of final results...
January 8, 2018: Trials
https://www.readbyqxmd.com/read/29301001/the-gateway-from-near-into-remote-oceania-new-insights-from-genome-wide-data
#2
Irina Pugach, Ana T Duggan, D Andrew Merriwether, Françoise R Friedlaender, Jonathan S Friedlaender, Mark Stoneking
A widely accepted two-wave scenario of human settlement of Oceania involves the first out-of-Africa migration ca 50,000 ya, and one of the most geographically-widespread dispersals of people, known as the Austronesian expansion, which reached the Bismarck Archipelago by about 3,450 ya. While earlier genetic studies provided evidence for extensive sex-biased admixture between the incoming and the indigenous populations, some archaeological, linguistic and genetic evidence indicates a more complicated picture of settlement...
January 2, 2018: Molecular Biology and Evolution
https://www.readbyqxmd.com/read/29300782/the-paradox-of-hbv-evolution-as-revealed-from-a-16th-century-mummy
#3
Zoe Patterson Ross, Jennifer Klunk, Gino Fornaciari, Valentina Giuffra, Sebastian Duchêne, Ana T Duggan, Debi Poinar, Mark W Douglas, John-Sebastian Eden, Edward C Holmes, Hendrik N Poinar
Hepatitis B virus (HBV) is a ubiquitous viral pathogen associated with large-scale morbidity and mortality in humans. However, there is considerable uncertainty over the time-scale of its origin and evolution. Initial shotgun data from a mid-16th century Italian child mummy, that was previously paleopathologically identified as having been infected with Variola virus (VARV, the agent of smallpox), showed no DNA reads for VARV yet did for hepatitis B virus (HBV). Previously, electron microscopy provided evidence for the presence of VARV in this sample, although similar analyses conducted here did not reveal any VARV particles...
January 2018: PLoS Pathogens
https://www.readbyqxmd.com/read/29273718/successful-reconstruction-of-whole-mitochondrial-genomes-from-ancient-central-america-and-mexico
#4
Ana Y Morales-Arce, Courtney A Hofman, Ana T Duggan, Adam K Benfer, M Anne Katzenberg, Geoffrey McCafferty, Christina Warinner
The northern and southern peripheries of ancient Mesoamerica are poorly understood. There has been speculation over whether borderland cultures such as Greater Nicoya and Casas Grandes represent Mesoamerican outposts in the Isthmo-Colombian area and the Greater Southwest, respectively. Poor ancient DNA preservation in these regions challenged previous attempts to resolve these questions using conventional genetic techniques. We apply advanced in-solution mitogenome capture and high-throughput sequencing to fourteen dental samples obtained from the Greater Nicoya sites of Jícaro and La Cascabel in northwest Costa Rica (n = 9; A...
December 22, 2017: Scientific Reports
https://www.readbyqxmd.com/read/29246361/neonatal-and-infant-mortality-risk-associated-with-preterm-and-small-for-gestational-age-births-in-tanzania-individual-level-pooled-analysis-using-the-intergrowth-standard
#5
Ayesha Sania, Emily R Smith, Karim Manji, Christopher Duggan, Honorati Masanja, Rodrick Kisenge, Gernard Msamanga, Willy Urassa, Wafaie Fawzi
OBJECTIVES: To evaluate the risk of newborn and infant mortality associated with preterm, small for gestational age (SGA), and low birth weight (LBW) stratified by maternal HIV status and the location of birth. STUDY DESIGN: We created a prospective cohort by pooling 5 individually randomized trials. We used Cox proportional hazard models to estimate the risk of mortality for SGA defined using the recently published Intergrowth standard, preterm, LBW, and gestational age and size for gestational age categories (preterm- appropriate for gestational age [AGA], term-SGA, and preterm-SGA)...
January 2018: Journal of Pediatrics
https://www.readbyqxmd.com/read/29233843/cesarean-delivery-rates-among-family-physicians-versus-obstetricians-a-population-based-cohort-study-using-instrumental-variable-methods
#6
Russell Eric Dawe, Jessica Bishop, Amanda Pendergast, Susan Avery, Kelly Monaghan, Norah Duggan, Kris Aubrey-Bassler
BACKGROUND: Previous research suggests that family physicians have rates of cesarean delivery that are lower than or equivalent to those for obstetricians, but adjustments for risk differences in these analyses may have been inadequate. We used an econometric method to adjust for observed and unobserved factors affecting the risk of cesarean delivery among women attended by family physicians versus obstetricians. METHODS: This retrospective population-based cohort study included all Canadian (except Quebec) hospital deliveries by family physicians and obstetricians between Apr...
December 11, 2017: CMAJ Open
https://www.readbyqxmd.com/read/29219102/canadian-24-hour-movement-guidelines-for-the-early-years-0-4%C3%A2-years-an-integration-of-physical-activity-sedentary-behaviour-and-sleep
#7
Mark S Tremblay, Jean-Philippe Chaput, Kristi B Adamo, Salomé Aubert, Joel D Barnes, Louise Choquette, Mary Duggan, Guy Faulkner, Gary S Goldfield, Casey E Gray, Reut Gruber, Katherine Janson, Ian Janssen, Xanne Janssen, Alejandra Jaramillo Garcia, Nicholas Kuzik, Claire LeBlanc, Joanna MacLean, Anthony D Okely, Veronica J Poitras, Mary-Ellen Rayner, John J Reilly, Margaret Sampson, John C Spence, Brian W Timmons, Valerie Carson
BACKGROUND: The Canadian Society for Exercise Physiology convened representatives of national organizations, research experts, methodologists, stakeholders, and end-users who followed rigorous and transparent guideline development procedures to create the Canadian 24-Hour Movement Guidelines for the Early Years (0-4 years): An Integration of Physical Activity, Sedentary Behaviour, and Sleep. These novel guidelines for children of the early years embrace the natural and intuitive integration of movement behaviours across the whole day (24-h period)...
November 20, 2017: BMC Public Health
https://www.readbyqxmd.com/read/29216042/the-small-molecule-clp257-does-not-modify-activity-of-the-k-cl-co-transporter-kcc2-but-does-potentiate-gabaa-receptor-activity
#8
Ross A Cardarelli, Karen Jones, Lucie I Pisella, Heike J Wobst, Lisa J McWilliams, Paul M Sharpe, Matthew P Burnham, David J Baker, Ilona Chudotvorova, Justine Guyot, Liliya Silayeva, Danielle H Morrow, Niek Dekker, Stephen Zicha, Paul A Davies, Jörg Holenz, Mark E Duggan, John Dunlop, Robert J Mather, Qi Wang, Igor Medina, Nicholas J Brandon, Tarek Z Deeb, Stephen J Moss
No abstract text is available yet for this article.
December 7, 2017: Nature Medicine
https://www.readbyqxmd.com/read/29205053/2017-white-paper-rise-of-hybrid-lba-lcms-immunogenicity-assays-part-2-hybrid-lba-lcms-biotherapeutics-biomarkers-immunogenicity-assays-and-regulatory-agencies-inputs
#9
Hendrik Neubert, An Song, Anita Lee, Cong Wei, Jeff Duggan, Keyang Xu, Eric Woolf, Chris Evans, Joe Palandra, Omar Laterza, Shashi Amur, Isabella Berger, Mark Bustard, Mark Cancilla, Shang-Chiung Chen, Seongeun Julia Cho, Eugene Ciccimaro, Isabelle Cludts, Laurent Cocea, Celia D'Arienzo, Lieza Danan-Leon, Lorella Di Donato, Fabio Garofolo, Sam Haidar, Akiko Ishii-Watabe, Hao Jiang, John Kadavil, Sean Kassim, Pekka Kurki, Olivier Le Blaye, Kai Liu, Rod Mathews, Gustavo Mendes Lima Santos, Makoto Niwa, João Pedras-Vasconcelos, Mark Qian, Brian Rago, Ola Saad, Yoshiro Saito, Natasha Savoie, Dian Su, Matthew Szapacs, Nilufer Tampal, Stephen Vinter, Jian Wang, Jan Welink, Emma Whale, Amanda Wilson, Y-J Xue
The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid ligand binding assay (LBA)/LCMS and LBA approaches...
December 2017: Bioanalysis
https://www.readbyqxmd.com/read/29183404/prolonged-prostaglandin-e2-associated-periosteal-reaction-and-elevated-c-reactive-protein-levels
#10
Maria I Duggan, Andrew T MacLaren, Dhullipala Anand
This is a case review of two infants who received a prolonged course of prostaglandin-E2 therapy for congenital cardiac lesions while awaiting corrective surgery. These cases highlight an association between prolonged prostaglandin-E2 therapy with periosteal reactions and elevated C-reactive protein levels. Failure to recognise this association may lead to multiple courses of antibiotics for presumed sepsis and further prolongation of prostaglandin-E2 therapy.
November 29, 2017: Cardiology in the Young
https://www.readbyqxmd.com/read/29175223/implementation-of-a-mindfulness-moment-initiative-for-healthcare-professionals-perceptions-of-facilitators
#11
Karen Duggan, Kell Julliard
CONTEXT: Mindfulness practices in the workplace have experienced rapid growth, with initial evidence suggesting positive outcomes. Even so, little is known about implementing mindfulness-based interventions (MBI), especially internally driven programs led by volunteers rather than experts. OBJECTIVE: This study qualitatively explores volunteer facilitators' perceptions of a short-dose MBI (the mindfulness moment initiative) before and 6 weeks after implementation...
November 23, 2017: Explore: the Journal of Science and Healing
https://www.readbyqxmd.com/read/29173323/delayed-breastfeeding-initiation-is-associated-with-infant-morbidity
#12
Emily R Smith, Lindsey M Locks, Karim P Manji, Christine M McDonald, Roland Kupka, Rodrick Kisenge, Said Aboud, Wafaie W Fawzi, Christopher P Duggan
OBJECTIVE: To assess the relationship between breastfeeding initiation time and postneonatal mortality, morbidity, and growth through 24 months in a cohort of Tanzanian infants. STUDY DESIGN: We included 4203 infants from 2 trials of micronutrient supplementation. We used Cox proportional hazards models or general estimating equations to estimate relative risks. RESULTS: A total of 13% of infants initiated breastfeeding >1 hour after birth (n = 536)...
December 2017: Journal of Pediatrics
https://www.readbyqxmd.com/read/29160734/immunoparesis-and-polyclonal-immunoglobulin-recovery-after-auto-sct-for-patients-with-multiple-myeloma-treated-at-a-single-institution
#13
Victor H Jimenez-Zepeda, Peter Duggan, Paola Neri, Ahsan Chaudhry, Jason Tay, Nizar Bahlis
Immunoparesis and polyclonal immunoglobulin recovery have been recently described as common indicators of immune dysfunction in patients with multiple myeloma. In the present study, we aimed to assess the impact of immunoparesis and polyclonal immunoglobulin recovery at day-100 post autologous stem cell transplant (auto-SCT) on clinical outcomes. A total of 302 patients were included for the analysis of immunoparesis, and 197 were evaluable for polyclonal immunoglobulin recovery evaluation. Immunoparesis was observed in 93...
November 21, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/29158114/early-relapse-for-multiple-myeloma-patients-undergoing-single-autologous-stem-cell-therapy-a-single-center-experience
#14
Holly Lee, Peter Duggan, Ahsan Chaudhry, Paola Neri, Jason Tay, Fariborz Rashid-Kolvear, Nizar J Bahlis, Victor H Jimenez-Zepeda
INTRODUCTION: Multiple myeloma is a heterogeneous disease with diverse clinical courses and patient outcomes. Although the introduction of novel agents has improved the overall survival (OS) of multiple myeloma patients, reports have highlighted that a subset of patients persists who experience early relapse (ER) and whose prognosis is significantly poorer than that of patients with a longer therapy response. METHODS: The purpose of the present study was to understand the effect of ER on OS and identify other predictors of OS...
November 1, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/29150411/an-epithelial-biomarker-signature-for-idiopathic-pulmonary-fibrosis-an-analysis-from-the-multicentre-profile-cohort-study
#15
Toby M Maher, Eunice Oballa, Juliet K Simpson, Joanne Porte, Anthony Habgood, William A Fahy, Aiden Flynn, Philip L Molyneaux, Rebecca Braybrooke, Hrushikesh Divyateja, Helen Parfrey, Doris Rassl, Anne-Marie Russell, Gauri Saini, Elisabetta A Renzoni, Anne-Marie Duggan, Richard Hubbard, Athol U Wells, Pauline T Lukey, Richard P Marshall, R Gisli Jenkins
BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal disorder with a variable disease trajectory. The aim of this study was to assess potential biomarkers to predict outcomes for people with IPF. METHOD: PROFILE is a large prospective longitudinal cohort of treatment-naive patients with IPF. We adopted a two-stage discovery and validation design using patients from the PROFILE cohort. For the discovery analysis, we examined 106 patients and 50 age and sex matched healthy controls from Nottingham University Hospitals NHS Trust and the Royal Brompton Hospital...
November 14, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29148835/2017-white-paper-on-recent-issues-in-bioanalysis-aren-t-bmv-guidance-guidelines-scientific-part-1-lcms-small-molecules-peptides-and-small-molecule-biomarkers
#16
Jan Welink, Eric Yang, Nicola Hughes, Brian Rago, Eric Woolf, Jens Sydor, Laura Coppola, Brad Ackermann, Wenkui Li, Stephen C Alley, Mark Arnold, Isabella Berger, Chad Briscoe, Michael Buonarati, Mark Bustard, Mark Cancilla, Seongeun Julia Cho, Jeff Duggan, Daniela Fraier, Fabio Garofolo, Rachel Green, Sam Haidar, Lucinda Hittle, Akiko Ishii-Watabe, Rafiq Islam, Rand Jenkins, Barry Jones, John Kadavil, Sean Kassim, Olga Kavetska, Olivier Le Blaye, Anita Lee, Hanlan Liu, John Mehl, Gustavo Mendes Lima Santos, Adrien Musuku, Ragu Ramanathan, Yoshiro Saito, Natasha Savoie, Scott Summerfield, Sekhar Surapaneni, Matthew Szapacs, Nilufer Tampal, Tom Verhaeghe, Stephen Vinter, Emma Whale
The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis, Biomarkers and Immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small and large molecule analysis involving LCMS, hybrid LBA/LCMS and ligand-binding assay (LBA) approaches...
November 17, 2017: Bioanalysis
https://www.readbyqxmd.com/read/29144272/body-composition-in-children-with-chronic-illness-accuracy-of-bedside-assessment-techniques
#17
Enid E Martinez, Craig D Smallwood, Nicolle L Quinn, Katelyn Ariagno, Lori J Bechard, Christopher P Duggan, Nilesh M Mehta
OBJECTIVE: To evaluate the accuracy of estimated fat mass and fat-free mass from bedside methods compared with reference methods in children with chronic illnesses. STUDY DESIGN: Fat mass and fat-free mass values were obtained by skinfold, bioelectrical impedance analysis (BIA), dual-energy x-ray absorptiometry (DXA), and deuterium dilution method in children with spinal muscular atrophy, intestinal failure, and post hematopoietic stem cell transplantation (HSCT)...
November 2017: Journal of Pediatrics
https://www.readbyqxmd.com/read/29144271/different-cut-points-in-detecting-child-nutritional-disorders-where-do-we-draw-the-line
#18
Christopher Duggan
No abstract text is available yet for this article.
November 2017: Journal of Pediatrics
https://www.readbyqxmd.com/read/29134566/lisdexamfetamine-a-review-in-binge-eating-disorder
#19
Young-A Heo, Sean T Duggan
Oral lisdexamfetamine dimesylate (Vyvanse®; lisdexamfetamine), a prodrug of dextroamfetamine, is currently the only drug to be approved in the USA for the treatment of moderate to severe binge eating disorder (BED) in adult patients. Its approval was based on the results of two pivotal short-term (12 weeks) phase III studies, which showed a significantly greater reduction in binge eating days/week at the end of the study with lisdexamfetamine 50-70 mg/day than with placebo. The findings of these studies have been supported and extended by the results of longer-term (≤ 52 weeks) phase III studies, including one with a randomized 26-week withdrawal phase, which showed that lisdexamfetamine markedly reduced the risk of BED relapse relative to placebo...
November 2017: CNS Drugs
https://www.readbyqxmd.com/read/29129351/is-serum-methylmalonic-acid-a-reliable-biomarker-of-vitamin-b12-status-in-children-with-short-bowel-syndrome-a-case-series
#20
Lissette Jimenez, Danielle A Stamm, Brittany Depaula, Christopher P Duggan
We describe 3 patients with short bowel syndrome who had persistently elevated serum methylmalonic acid (MMA) levels while being treated for vitamin B12 deficiency. Following treatment for presumed small bowel bacterial overgrowth, MMA levels normalized. Among patients with short bowel syndrome, MMA levels may have limited specificity for vitamin B12 deficiency.
January 2018: Journal of Pediatrics
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